I. Field of the Disclosure
The present invention relates to an apparatus, system, and method for fastening tissue and/or fastening a prosthetic/biologic mesh to tissue. Specifically, it is designed for use in anastomosis surgery (i.e. connecting two tubular structures) to restore continuity after resection, to bypass an unresectable disease process, to close any luminal structure, to provide hemostasis, or to position/secure bioabsorbable or prosthetic mesh for tissue or organ structural weakness. The present invention relates to the process of performing an anastomosis in an end-to-end, side-to-side or an end-to-side fashion as a functional example, but fastening open edges of tissue, securing prosthetic material to tissue, or closure of a bleeding vessel can be accomplished in a similar fashion.
II. Description of the Related Art
The “background” description provided herein is for the purpose of generally presenting the context of the disclosure. Work of the presently named inventors, to the extent it is described in this background section, as well as aspects of the description which may not otherwise qualify as prior art at the time of filing, are neither expressly or impliedly admitted as prior art against the present invention.
There are many procedures for pediatric patients that include minimally invasive techniques, but there are few surgeons who are able to perform them due to the challenges they present. Because the patient's anatomy is so small, pediatric surgery faces access and space challenges not found in adult patients. The tiny volume available for tool movement and accommodation when using standard laparoscopic techniques inside the pediatric patient make standard tools unusable; they are simply too large. Once inside the patient, the ability to obtain good camera views is constrained due to limited space availability. This, combined with the reduced size of the anatomy, challenges the surgeon's situational awareness at a time in in the procedure that is especially critical for efficacy.
A common requirement in many surgical procedures is the resection or bypass of a diseased organ. Often the diseased section involves a tubular structure (i.e. artery, bowel, or esophagus) and the resulting ends of the tube must be reattached after performing the resection. This procedure is termed an “anastomosis” and is less difficult to perform in the setting of an open surgery. However, in minimally invasive surgery (MIS) where the procedure is performed through small incisions in the patient's skin, it is extremely difficult to create an anastomosis due to limited space, inadequate camera visualization, and awkward instrument angles. Of all the tasks performed during pediatric minimally invasive surgery, anastomosis creation is probably the most critical to success, and is the portion of the procedure most likely to be impacted by operating constraints. In some cases, it may take as long as two hours to perform. For the surgeon, laparoscopic anastomosis surgery is extremely difficult to learn and perform and is very fatiguing in nature. Increased operating time is also a burden on the healthcare system as it consumes valuable operating room time and adds to overall costs. Most importantly, spending an extended period of time in surgery can negatively impact the patient due to increased anesthesia requirement and additional stress to the body.
U.S. Pat. No. 6,358,258 issued to Arcia et al. discloses an anastomosis device that utilizes multiple flexible needles (designed of nitinol material) that are deployed through multiple curved guide channels. The design utilizes multiple push rods for actuation and is suitable for end-side type anastomosis.
U.S. Pat. No. 7,029,481 issued to Burdulis et al. discloses an anastomosis device that utilizes multiple needles that are simultaneously is pierced through the tissue using a pneumatic cylinder. The needles latch onto small crimps on the opposite end and pull the sutures through the tissue upon retraction. The other end of the device utilizes multiple flexible needles deployed using curved channels and multiple pushrods. The design needs custom needles as the sutures are attached to the distal tip of the needle as opposed to the proximal end found in conventional sutures.
U.S. Patent Application No. 2008/10275472 to Yossepowitch et al. discloses an anastomosis device that utilizes multiple needle deployment through the use of flexible needle and curved guide channels. The design utilizes multiple push rods and requires custom needles to function. Even though the two ends of the design are attached through a flexible coupler, the design lacks a good suture management scheme and will suffer from suture tangling. As described in U.S. Pat. No. 7,029,481, the design requires custom needles as the sutures are attached to the distal tip of the needle as opposed to the proximal end found in conventional sutures.
U.S. Pat. No. 8,123,764 issued to Meade et al. discloses a minimally invasive suturing device that utilizes an actuator that engages a curved suturing needle to cause rotational movement and advance the needle, along with the attached suturing material, through separate segments of tissue thereby forming a stitch. The design provides a good method of creating a stitch, but tying of the suturing material requires a separate discrete process that necessitates input of a laparoscopic grasping tool through a separate port, introducing additional time and uncertainty to the surgical procedure. Furthermore, like conventional method of laparoscopic anastomosis, an additional step of exchanging a grasping tool to a cutting tool is required to remove the suturing material from the needle in order to retrieve the latter.
Aside from the aforementioned patents, various MIS suturing devices are described in the following patents: U.S. Pat. No. 5,954,733 (Yoon) entitled “Suturing Instrument with Rotatably Mounted Needle Driver and Catcher,” U.S. Pat. No. 5,665,096 (Yoon) entitled “Needle Driving Apparatus and Methods of Suturing Tissue,” U.S. Pat. No. 5,665,109 (Yoon) entitled “Methods and Apparatus for Suturing Tissue,” U.S. Pat. No. 5,759,188 (Yoon) entitled “Suturing Instrument with Rotatably Mounted Needle Driver and Catcher,” U.S. Pat. No. 5,860,992 (Daniel et al.) entitled “Endoscopic Suturing Devices and Methods,” U.S. Pat. No. 6,719,763 (Chung) entitled “Endoscopic Suturing Device,” and U.S. Pat. No. 6,755,843 (Chung) “Endoscopic Suturing Device,” U.S. Pat. No. 8,100,922 entitled “Curved Needle Suturing Tool” (Ethicon Endo-Surgery), U.S. Pat. No. 6,425,887 entitled “Multidirectional Needle Medical Device” (Cook Incorporated), U.S. Patent Application No. 2003/0032929 entitled “Hollow Curved Superelastic Medical Needle and Method” (Rex Medical); and U.S. Patent Application No. 2008/0097391 entitled “Articulating Laparoscopic Device and Method for Delivery of Medical Fluid” (Rex Medical).